PROSTHETIC VALVE WITH SEMI-RIGID AND FLEXIBLE LEAFLETS

• US 20100174361A1
• Filed: 03/15/2010
• Published: 07/08/2010
• Est. Priority Date: 01/29/2007
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Bailey, Frances Kristen, Paul, Ram H. JR.
• Application Number:
  US12/723,840
• Publication Number:
  US 20100174361A1
• Time in Patent Office: Days
• US Class Current: 623/2.200
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

The invention relates to a prosthetic valve for regulating fluid flow through a body lumen. The valve includes a frame and a valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet.

Claims

1. A valve prosthesis for implantation within a lumen of a body vessel, said valve prosthesis comprising:

a frame;

a semi-rigid leaflet attached to the frame and having a first free edge; and

a flexible leaflet attached to the frame and having a second free edge, the flexible leaflet being moveable between a first position that permits fluid flow through said prosthesis in a first direction and a second position in which at least a portion of the flexible leaflet coapts with at least a portion of the semi-rigid leaflet to substantially prevent fluid flow through said valve prosthesis in a second direction.

2. The valve prosthesis of claim 1, wherein the semi-rigid leaflet and the flexible leaflet comprise different materials.

3. The valve prosthesis of claim 2, wherein the semi-rigid leaflet further comprises reinforcing material selected from the group consisting of threads, fibers, meshes, and wires.

4. The valve prosthesis of claim 1, wherein one of the flexible leaflet and the semi-rigid leaflet comprises a material selected from the group consisting of extracellular matrix material, xenogenic biomaterials, autologous tissue, allogeneic tissue, and polymeric materials.

5. The valve prosthesis of claim 1, wherein one of the flexible leaflet and the semi-rigid leaflet comprises small intestine submucosa.

6. The valve prosthesis of claim 1, wherein the first free edge comprises a curved free edge.

7. The valve prosthesis of claim 1, wherein one of the semi-rigid leaflet and the flexible leaflet define a leaflet surface comprising a curvature.

8. The valve prosthesis of claim 7, wherein the curvature comprises a convex or concave curvature.

9. The valve prosthesis of claim 1, wherein the flexible leaflet comprises a surface having a curvature approximating the curvature of said body vessel.

10. The valve prosthesis of claim 1, wherein each of the semi-rigid leaflet and the flexible leaflet has a curved surface adjacent the frame.

11. The valve prosthesis of claim 1, wherein each of the semi-rigid leaflet and the flexible leaflet has a varying thickness.

12. The valve prosthesis of claim 1, wherein one of the semi-rigid leaflet and the flexible leaflet comprises an opening that provides a passageway.

13. The valve prosthesis of claim 1, wherein the semi-rigid leaflet comprises a first opening providing a first passageway and the flexible leaflet comprises a second opening providing a second passageway.

14. The valve prosthesis of claim 1, wherein one of the semi-rigid leaflet and the flexible leaflet is adapted to cooperatively define an opening with said body vessel to provide a passageway.

15. The valve prosthesis of claim 1, wherein the semi-rigid leaflet has a length that is between about 25% and about 60% of a diameter of said body vessel.

16. The valve prosthesis of claim 1, wherein the flexible leaflet has a length that is between about 40% and about 75% of a diameter of said body vessel.

17. The valve prosthesis of claim 1, wherein the frame is self-expanding.

18. The valve prosthesis of claim 1, wherein the frame comprises stainless steel or nitinol.

19. A valve prosthesis for implantation within a lumen of a body vessel, said valve prosthesis comprising:

a frame;

a semi-rigid leaflet attached to the frame and having a first free edge, the semi-rigid leaflet comprising an opening providing a passageway; and

a flexible leaflet attached to the frame and having a second free edge, the flexible leaflet being moveable between a first position that permits fluid flow through said prosthesis in a first direction and a second position in which at least a portion of the flexible leaflet coapts with at least a portion of the semi-rigid leaflet to substantially prevent fluid flow through said valve prosthesis in a second direction;

wherein the semi-rigid leaflet has a length that is between about 25% and about 60% of a diameter of said body vessel.

20. A valve prosthesis for implantation within a lumen of a body vessel, said valve prosthesis comprising:

a frame;

a semi-rigid leaflet attached to the frame and having a first free edge, the semi-rigid leaflet adapted to cooperatively define an opening with said body vessel to provide a passageway disposed substantially opposite the first free edge; and

a flexible leaflet attached to the frame and having a second free edge, the flexible leaflet being moveable between a first position that permits fluid flow through said prosthesis in a first direction and a second position in which at least a portion of the flexible leaflet coapts with at least a portion of the semi-rigid leaflet to substantially prevent fluid flow through said valve prosthesis in a second direction;

wherein the semi-rigid leaflet has a length that is between about 25% and about 60% of a diameter of said body vessel.